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Registration guides for therapeutic products

Register your therapeutic products before you supply them in Singapore. Select the appropriate registration guide to get started.

New drug application Once you have decided to submit a new drug application, use this guide to find out the documents, fees and processing time required to complete the registration. Generic drug application Once you have decided to submit a generic drug application, use this relevant guide to find out the documents, fees and processing time required to complete the registration. Biosimilar product application Follow this guide to find out the documents, fees and processing time needed to complete your biosimilar product application for a therapeutic product. Submission of Drug Master File Follow this guide to find out the processes for the submission and processing of a Drug Master File for a therapeutic product registration. Submission of Plasma Master File Follow this guide to find out the processes for the submission and processing of a Plasma Master File for a therapeutic product application.

Last updated: 31 Dec 2018